Kornimate/medical-research-clean huggingface dataset:
radical prostatectomy versus radical radiotherapy for locally advanced prostate cancer

Conditions: Prostatic Neoplasms

Summary: this prospective, open randomized clinical trial seeks to investigate whether radical prostatectomy with androgen deprivation therapy improves prostate-cancer specific survival and quality of life in comparison with radical radiation treatment with androgen deprivation therapy among patients diagnosed locally advanced prostate cancer. lack of extensive psa screening in mainland china, many new cases of prostate cancer are lapca. surgery and/or radiation plus attempted chemotherapy are curative treatment for advanced solid malign tumors to control and eliminate the local and micro metastases. lapca is easy to metastasis, relapse and has a poor prognosis. for lapca, a single rp approach is generally not the preferred option because it is generally considered that radical surgery is difficult to completely remove the lesion and the long-term prognosis is not ideal. however, androgen deprivation therapy promotes the prognosis of lapca with lymph nodes or seminal vesicle metastases and improves the local control rate of tumor. what is more, for early localized prostate cancer, rt has similar efficacy to rp, for advanced tumor rt can not only relieve urinary tract obstruction and other symptoms, but also improve biochemical progression free survival and local oncological control. a randomized clinical trial comparing two multimodal treatment including rp or rt with adt regimens is therefore warranted.


Eligibility criteria:
inclusion criteria: 1. 18≤age ≤75, at the time of randomization. 2. confirmed as non-metastatic prostate adenocarcinoma by transrectal ultrasound biopsy in six months before enrollment and untreated. 3. tumor stage (t, m, n): according to 2018 nccn prostate cancer guidelines t3 stage significant extra-capsular tumor extension m0 (no sign of distant metastases) nx (regional lymph nodes cannot be assessed). for patients with t4, the tumor should be confined to the bladder neck, and bilateral ureters should not be invaded. 4. who score 0-1, ecog score 0-2, and asa grade i-iii. 5. at least 5 years life expectancy. 6. the general condition and mental status of patients shall permit observation in accordance with the study protocol. 7. signed informed consent. exclusion criteria: 1. concomitant with other malignancies. 2. with severe systemic disease (cardio-cerebrovascular disease, etc.) cannot tolerate surgery or radiotherapy. 3. clinical significant abnormal laboratory values at the discretion of the investigator, e.g. severe kidney function gfr \ 10 uln. 4. involved in other clinical trials simultaneously. 5. any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
mri study of radiation-induced damage to white matter and blood-brain-barrier

Conditions: Brain Neoplasms

Summary: this is a study to determine if magnetic resonance imaging (mri) techniques can detect early changes in white matter (in the brain) and the blood-brain barrier resulting from radiation therapy.

patients will be assigned to one of two groups based on the type of radiation they will be receiving: whole brain irradiation or partial brain irradiation. patients will undergo magnetic resonance imaging (mri) assessments, neurocognitive testing (quality of life and neuropsychological assessments), and clinical evaluation.

Eligibility criteria:
inclusion criteria: * patients receiving partial brain irradiation for malignant or benign brain tumors (including low-grade gliomas, high-grade gliomas, malignant meningioma, pituitary adenomas, supratentorial meningioma, or craniopharyngiomas); or patients receiving whole brain irradiation for brain metastases. * patients must be 18 years of age or older * patients must sign a study specific consent form approved by the institutional review board (irb) of the university of michigan prior to study entry. * patients must have a neurological function class 1 or 2 with a karnofsky performance status (a scoring system used to quantify general well being and quality of life on a scale of 100 to 0) of greater than or equal to 70. * patients must have an expected life expectancy of greater than 6 months. exclusion criteria: * patients with a history of major medical illness or psychiatric impairment which, in the investigator's opinion, will prevent administration of the protocol. * patients who have had prior external beam irradiation to the brain or head/neck area that will lead to overlap of the radiation field. * patients should have no contraindications to having a contrast enhanced magnetic resonance imaging (mri) scan. * prisoners are excluded. * pregnant women are excluded.
effects of ward cats in patients with substance abuse, depression and psychosis at upk basel

Conditions: Satisfaction; Station Atmosphere

Summary: the aim of this study is to explore the relationship between ward cats and patient satisfaction and stations atmosphere in patients with substance abuse, depression and psychosis. moreover, we wanted to investigate the patients perception of the ward cats and the relationship between station atmosphere perceived by the employees working wards with and without cat at ukp basel.

the following tools were used to address these aims: * available müpf data regarding patient satisfaction of 170 inpatients during 2016 was analyzed. * available müpf data regarding patient satisfaction of 151 inpatients during 2017 was analyzed. * 33 patients were interviewed regarding their perception of the cats * 30 staff members at the wards filled in questionnaires regarding station atmosphere (essences)

Eligibility criteria:
inclusion criteria: * inpatient of the 7 wards at upk basel diagnosed with substance abuse, depression and psychosis * staff working at these wards exclusion criteria: * none
effect of sacubitril/valsartan on cardiac function in hypertensive patients stratified by bmi: a real world study

Conditions: Sacubitril/Valsartan; Hypertension; Obesity

Summary: the purpose of this study is to investigate the effect of sacubitril/valsartan on cardiac function assessed by cardiac magnetic resonance (cmr) in hypertensive patients stratified by bmi.

obesity is one of the risk factors of hypertension, and affects cardiac structure and function in the long term for hypertensive patients. sacubitril/valsartan is regarded as a better antihypertensive drug for the improvement of cardiac function for patients with heart failure, but it remains unclear whether there are differences among different bmi groups. therefore, the aim of this study was to evaluate the benefit of sacubitril/valsartan versus other antihypertensive drugs on cardiac structure and function assessed by cmr in hypertensive patients stratified by bmi in the real world.

Eligibility criteria:
inclusion criteria: * patients with essential hypertension * 18-70 years old * no major barriers to provide written consent exclusion criteria: * secondary hypertension, except because of sleep apnea * cardiovascular disease (myocardial infarction, heart failure, stroke or coronary revascularization) within 6 months * severe concomitant diseases (autoimmune disease, malignancy, late stage of liver diseases, respiratory diseases and digestive diseases) * unable to understand or comply with the study procedures

Keywords: cardiac function cardiac magnetic resonance
insights into participating in clinical studies for anorexia

Conditions: Anorexia

Summary: clinical trials centered on anorexia serve a pivotal function in assessing the safety and effectiveness of emerging treatments for this condition. the primary aim revolves around meticulously scrutinizing both trial completion rates and instances of voluntary withdrawal within specific patient cohort.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * diagnosis of anorexia * no prior treatment for anorexia exclusion criteria: * pregnant or lactating women * any serious and/or unstable pre-existing medical disorders * patients receiving any other investigational agents

Keywords: anorexia
postpartum perineal pain after obstetric anal sphincter injuries

Conditions: Pain; Postpartum Depression

Summary: obstetric anal sphincter injuries (oasis) encompass both third and fourth degree perineal tears. these tears can have a significant impact on women's quality of life in the short and long term. one of the most distressing immediate complications of this severe perineal injury is perineal pain. women can also experience postpartum depression, dyspareunia, and altered sexual function after oasis. this is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after oasis. the objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.


Eligibility criteria:
inclusion criteria: * age \>18 years of age * english-speaking * vaginal delivery (spontaneous or assisted) * a full-term fetus (\>37 weeks' gestation) * oasis as assessed by obstetrical provider * functional epidural analgesia at time of delivery * patient amenable to follow-up in specialty perineal clinic within the first week postpartum exclusion criteria: * previous pelvic surgery * history of chronic pelvic pain * history of recurrent urinary tract infections * women with known malformations of their urinary tract * true allergies to ketamine and/or morphine * preeclampsia or hypertensive disorder at the time of delivery * obstructive sleep apnea
biomarkers correlation with volemia

Conditions: Cerebral Hemorrhage; Head Injury; Non Traumatic Post Surgery; Poly Trauma Patients Without Heart Failure; Renal Insufficiency

Summary: the purpose of this study is to determine whether the biomarkers (pro adrenomedullin (mr proadm), pro arginin vasopressin (ct proavp), pro atrial natriuretic peptid (mr proanp), pro endothelin) changes at day 2, day 5 and day 7 of icu admission are correlated with intravascular volume assessed by cr 51 on red blood cells (day 2 and day 7) and by i 125 on albumine day 7. the correlation of these biomarkers are also evaluted with other markers such as erythropoietin and catecholamines. 80 icu patients are included.


Eligibility criteria:
inclusion criteria: * 20 cerebral hemorrhage * 20 head injury * 20 post surgery non traumatic non neuro * 20 polytrauma patients exclusion criteria: * heart failure nyha iii or iv * renal insufficiency creatinin clearance \< 30 ml/mn * age \< 18 y * pregnancy

Keywords: proadm proanp proendothelin proavp cr 51 volemia fluid management icu patients poly trauma patients
quantitative hpv genotyping in screening of anal intraepithelial neoplasia in hiv-positive patients

Conditions: Human Immunodeficiency Virus

Summary: the pathophysiology from anal hpv infection to anal intraepithelial neoplasia is less well understood than cervical hpv infection. in cervical screening programs it is well accepted that the sole presence of a high-risk hpv strain (irrespective of number of viral particles) is sufficient to justify further investigation and treatment. the investigators hypothesize that in anal hpv infection not only the presence but the extent of hpv infection (single genotype viral load) or combination of different hpv genotypes (cumulative viral load) is of importance in determining the risk of anal dysplasia.


Eligibility criteria:
inclusion criteria * stable hiv disease (i.e. receiving art for at least 1 year, no adverse drug reactions requiring regular monitoring, no current illnesses or pregnancy, good understanding of lifelong adherence and evidence of treatment success: two consecutive undetectable viral load measures) * referred for high-resolution anoscopy exclusion criteria * documented ain (treated or untreated) * local anal inflammation (proctitis) and/or acute fissure

Keywords: human papilloma virus anal intraepithelial neoplasia
study of a-319 in patients with relapsed or refractory b-cell lymphoma

Conditions: Relapsed or Refractory B-cell Lymphoma

Summary: title: a phase i, single centre, open-label, dose-escalation study of a-319 in patients with relapsed or refractory b-cell lymphoma

protocol number: sp071744 study stage: phase i study number: 1 site subject number: up to 54 patients with relapsed or refractory b-cell lymphoma

Eligibility criteria:
inclusion criteria: * 18-75 years, all genders * patients with definite b-cell lymphoma, includes fl, mzl, mcl, dlbcl. * patients with relapsed or refractory b-cell lymphoma * ecog ≤ 2 * lesions are measurable in 21 days before treatment * normal bone marrow function * normal liver, kidney, lung and heart function * the subjects can sign the icf and obey the protocol, elsewise, his/her guardian should sign * life expectancy is at least 3 months exclusion criteria:• past or present cns disease * associated with lymphoma by the infiltrates of cns * a history of autoimmune disease with cns involvement or autoimmune disease * previous history of autoimmune disease or other malignancy * a history of deep venous thrombosis or pulmonary embolism * auto-hsct was performed within 12 weeks prior to initiation of treatment * previous organ transplantation or allogeneic hematopoietic stem cell transplantation * the investigator determined that the patients were associated with a disease, medical condition, or social factor that might affect study results or compliance * immunosuppressant are being used * radiotherapy was given within 6 weeks prior to a-319 treatment * chemotherapy, immunotherapy and targeted therapy were received within 4 weeks before a-319 treatment * previous car-t cell therapy * received anti-lymphoma drugs in the first 4 weeks of a-319 treatment * there was no recovery of toxic effects (ctcae\> grade 1 adverse events) at the last treatment, except hair loss * those who underwent major surgery 28 days before enrollment (excluding lymph node biopsy);or plan to operate during the study period * those who had received active/attenuated live vaccine within 28 days prior to screening * for pregnant (positive pregnancy test) and lactating women, those of childbearing age who signed the informed consent form and did not agree to use contraception for at least 3 months after the end of the study;within 7 days prior to the first day of treatment, women of childbearing age require a positive serum pregnancy test (hcg) * male patients who signed informed consent forms and did not agree to use contraception for at least 3 months at the end of the study (except surgical sterilization) * known allergy to immunoglobulin or research drugs and their excipients * patients considered unfit to participate in the study
sodiumhexametaphosphate as pulp capping material for primary teeth

Conditions: Pulp Disease, Dental

Summary: sodiumhexametaphosphate will be tested as pulp capping material in comparison to mta for primary teeth pulp therapy


Eligibility criteria:
inclusion criteria: * physical healthy children * cooperative children * primary molar with deep carious lesion * absence of pain or transient momentary pain exclusion criteria: * uncooperative children * children with systemic disorders * periapical lesions * sever pain
aspirin resistance and stroke risk: platelet function analysis in patients with ischemic events

Conditions: Stroke; Myocardial Infarctions

Summary: the purpose of this study is to determine if pfa results correlate with ischemic event outcomes as well as bleeding complications. hypothesis is antiplatelet agents will be more efficacious if they are administered in a dose-adjusted manner using pfa results as a guide.

atherothrombotic disease is a leading killer of adults throughout the world. the current mainstay for the prevention of ischemic vascular events is the use of aspirin antiplatelet agents are used routinely for the primary and secondary prevention of vascular events in patients with a prior history of stroke, tia, or at high risk for the development of cerebrovascular disease. numberous individual studies and meta-analyses have shown that essentially all of the oral antiplatelet agents have limited efficacy, with relative risk reductions in the range of 20-35%. the purpose of this study is to perform serial platelet function assays (pfas) on patients with cerebrovascular disease who are taking antiplatelet agents and perform a pilot study to determine the feasibility of administering asa as a dose adjusted medication using pfa. the long term goal of this study is to determine whether antiplatelet therapy will be more efficacious and/or safer if it is administered in a dose-adjusted manner.

Eligibility criteria:
inclusion criteria: * patient must be taking aspirin or plavix * patient must have had a stroke, tia or cerebrovascular disease exclusion criteria: -none
phase 3 study to evaluate the efficacy and safety of the dw0929 in patients with primary hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to evaluate the efficacy and safety of the dw0929 in patients with primary hypercholesterolemia


Eligibility criteria:
inclusion criteria: * adult over 19years * patients with primary hypercholesterolemia whose ldl-c level is below 250mg/dl and tg level is below 350mg/dl * patients whose ldl-c level is under 'anti- dyslipidemia drug administration considered standard' of ncep atp iii(2004) * those who voluntarily written consent to participate in this clinical trial exclusion criteria: * uncontrolled hypertension * severe renal impairment(crcl\<30ml/min) * those who have active liver disease and whose alt, ast levels greater than twice the upper limit of normal * serum creatinine \> 2.0mg/dl * those who have been geunyukbyeong or rhabdomyolysis caused by using statin or have hypersensitivity to ezetimibe * combined cyclosporine -treated patients * hba1c ≥ 9% * tsh ≥ 1.5 x uln * hiv-positive person * congestive heart failure patients classified as nyha class iii or iv * patients with uncontrolled arrhythmias * patients who have malignant tumors needed chemotherapy, radiation therapy, etc. * blood clotting disorders * patients who had a myocardial infarction within 6 months or cardiovascular bypass surgery, patients who have underwent angioplasty * patients who had a history of anxiety or severe typical peripheral arterial disease within three months * women of childbearing age who don't agree with contraception during this clinical trials * pregnant women or nursing mothers * those who take the drug in combination taboo * who have been treated for another investigational drug within 30 days * unsuitable characters in a clinical trial to test self- determination
48 weeks, study to evaluate overall safety and tolerability of co-administration of tesofensine and metoprolol in subjects with hypothalamic injury-induced obesity (hio)

Conditions: Hypothalamic Injury-induced Obesity (HIO)

Summary: double-blind, randomized, placebo-controlled, single- center study followed by an open-label extension period. • the study will have two parts: * part 1: 24 weeks double-blind treatment (db), followed by * part 2: 24 weeks open-label extension (ole) - all subjects still participating at the end of part 1 will be given an option to continue for additional 24 weeks on the active drug if evaluated eligible by the investigator

part 1 - the double-blind (db) part: the active medication arm will be given co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks. the placebo arm will receive matching placebo tablets. part 2 - the open-label extension (ole) part: all active participants at the end of the double-blind part will be given the active medication 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks.

Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities * males and females, aged 18-75 * confirmed diagnosis of hio * bmi ≥27 kg/m2 (where overweight is related to the hio) exclusion criteria: * blood pressure (bp) ≥160/90 mmhg * heart rate (hr) ≥ 90, \<50 bpm * type 1 diabetes, cushings disease, acromegaly, hypophysitis, infiltrative diseases or prader-willi syndrome * heart failure new york heart association (nyha) level ii or greater, decompensated heart failure * previous myocardial infarction or stroke within the last 5 years
the effect of silicone hydrogel contact lenses on conjunctival flora

Conditions: Myopia

Summary: the primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. a secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.


Eligibility criteria:
inclusion criteria: * is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses. * is a current full time soft contact lens wearer. * has no clinically significant anterior eye findings. * has no other active ocular disease exclusion criteria: * has any systemic disease that might interfere with contact lens wear * is using any systemic or topical medications that will affect ocular health. * has any pre-existing ocular irritation that would preclude contact lens fitting. * has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses. * has undergone corneal refractive surgery. * is pregnant, lactating or planning a pregnancy. * is participating in a concurrent clinical trial. * has a latex sensitivity.
immunologic response to influenza vaccination in children and adolescents

Conditions: Influenza, Human; Immune Response

Summary: the purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-20 years of age. this is a randomized controlled trial (rct), that will assess immune response in 120 participants (60 per vaccine arm) pre- and post-vaccination to flucelvax (egg-free inactivated flu shot) and fluzone (egg-based inactivated flu shot).

this is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-20 years given one of two fda approved and licensed influenza vaccines: flucelvax (egg-free inactivated flu shot) and fluzone (egg-based inactivated flu shot). this study will enroll 120 healthy participants, 60 per vaccine arm. participants will be randomized using a 1:1 allocation to receive either flucelvax or fluzone. blood work will be conducted on all participants at baseline prior to vaccine receipt and post-vaccination at day 7 (range 6-9 days) and day 21 (range 21-35 days). the primary objective of the study is to determine pre and post serologic,responses to each vaccine type.

Eligibility criteria:
inclusion criteria: * aged 4-20 years; * has prior vaccination history available (which can be determined based either on medical record review or through state registry review; * plans to receive the current seasonal influenza vaccination at one of the recruiting sites exclusion criteria: * unable or unwilling to completed required study activities, including informed consent, randomization to vaccine, and bloodwork; * has already received influenza vaccine for the current season; * has a known immunocompromising condition or is on an immunosuppressing medication (e.g., high dose steroids \>10 days); * is known to be pregnant; * has a history of severe allergy to eggs or to influenza vaccine or any of its components

Keywords: inactivated influenza vaccine